Yesterday, Feb 26, the FDA’s vaccine advisory committee (VRBPAC) met to give its assent to the third Covid vaccine candidate applying for an Emergency Use Authorization (EUA). And I spent another day listening in. FDA is expected to authorize use of the vaccine today.
This one requires only one dose. For now. The company is doing a clinical trial of two doses and they could be recommended in future. The VRBPAC committee comments were lackluster. The members had little to go on. There is no adenovirus vaccine in civilian use in the US, just as there were no mRNA vaccines. The committee members simply don’t know what they have to watch out for. One admitted it, and asked if FDA would assist and suggest what types of issues the newly licensed Ebola adenovirus vaccine or the military adenovirus vaccine had faced. FDA responded with stony silence. Clearly this “advisory” meeting was only needed for its rubber stamp.
Most of the sponsor’s (Johnson and Johnson) presenters were from the Janssen division, based in Belgium. Many of the FDA’s presenters were non-native English speakers. The combination of an audio transmission that kept dropping out, and inability to catch many of the words made it a challenge to fully grasp the presentations. Was this intended?
FDA has refused to inspect the Covid vaccine manufacturing plants before they are “authorized” under EUA. I suspect FDA administrators were directed not to slow the warp speed down.
FDA will have to inspect the factories by law before Covid vaccines are fully licensed, but it seems that the game plan is to get the country vaccinated before adequate data become available and licensure can take place.
The CDC advisory committee has an emergency meeting scheduled for this Sunday and Monday (Feb 28 and March 1), presumably to give their blessing to the vaccine and recommend which demographics will get it first.
While Johnson and Johnson’s Janssen division designed and tested this new adenovirus vectored spike protein vaccine, the vaccine is actually being produced in a factory newly taken out of mothballs, with hundreds of new employees, that has never before produced a vaccine for mass use. It is owned by Emergent BioSolutions, a company notorious for poisoning soldiers with its anthrax vaccine, which has failed multiple anthrax vaccine inspections. On Emergent BioSolutions’ board is Kathryn Zoon, a former head of FDA’s Center for Biologics, which regulates vaccines.
This factory’s vaccine may not be exactly the same vaccine that about 20,000 subjects in the clinical trial have received. Usually vaccines for clinical trials are made in a pilot plant under stringent conditions.
Four million doses of the vaccine are ready to go out the door, with 100 million more promised through June. None of the committee members thought to ask FDA anything about the manufacturing arrangement.
Does the vaccine work? The vaccine is said to be 66% effective against moderate to severe disease in the trials, and 100% protective against death. In the clinical trials, having a headache and a cough was enough to put subjects in the “moderate to severe” category. Like the two mRNA vaccines, the vaccine sponsors apparently did not see fit to test whether their vaccines block infection and transmission in humans. This is the fault of the FDA, which sets the standard for the data needed to obtain an EUA.
Does it work against the South African strain? Reportedly almost as well as against the standard strain, but J and J is taking no chances. It is working on a new vaccine to combat newer variants, and Marion Gruber of FDA promised the committee yesterday that newer versions can zoom past FDA regulators with just a modicum of data.
Is it safe? What was the placebo? After a discussion, J and J’s lead corrected himself and said it was simply saline. The reported adverse events were practically identical between the saline placebo and the vaccine. Only hives, ringing in the ears (which eventually resolved) and a small number of blood clots were considered possible vaccine side effects. I have a hard time believing saline caused all those local (and systemic) effects. Only a subset of the subjects in the trials were evaluated for side effects. Why was that?
I can’t tell if this vaccine is safe and I doubt anyone else can, either. Nor do I want to be injected with something manufactured by the anthrax vaccine manufacturer, famed for injuring thousands of soldiers twenty years ago, while making 300% profit margins.
Americans either love or hate the Covid vaccines. The term vaccine seems to give them a luster they probably don’t deserve. How many Americans understand they are all experimental, unlicensed products, only permitted for use under an “Emergency Use Authorization” rule that require a minimum standard of evidence? The law simply says that in order to receive an authorization,
“the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under subsection (b)(1)(D), if applicable”
So, the more its sponsor knows about adverse effects, the more trouble the vaccine is likely to have getting its EUA. Accordingly, it is better for the adverse effects to be as unknown as possible.
Adenoviruses are double-stranded DNA viruses. So instead of mRNA, DNA coding for the spike protein has been inserted into an adenovirus. The virus will enter human cells and its DNA will enter the cell nucleus, which will then produce mRNA, and just like with the mRNA vaccines, our own cells will make spike proteins. For how long?
Subjects vaccinated with this vaccine developed increasing immunity over a prolonged period, suggesting that spike protein might be made for a long period of time. We don’t know for how long, nor how much is too much. But there are definite concerns about how spike proteins can potentially harm us, and how they may prime us for autoimmune reactions to either a Covid infection or to later doses of vaccine.
Are we guinea pigs? The EUA legislation specifies that recipients must be given considerably more information than is provided with other vaccines. I have included the language below. Still, I wonder how many recipients understand that they are part of a vast experiment, with the potential to cause very serious consequences?